Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

Phase 4

Completed

Conditions: Satisfaction
Cesarean Section Complications
Wound Breakdown
Wound Infection
Surgical Wound Infection

Interventions: Other: Standard Wound Care
Combination Product: ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)

Brief Summary: This will be an open label pilot randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine gluconate (CHG) impregnated wound dressing (ReliaTect™ Post-Op Dressing).

Detailed Description: Subjects requiring cesarean delivery and without exclusion criteria will be informed by the obstetrical team about the study and asked for permission to contact the study personnel. Written informed consent will be obtained by person-to-person contact. The research staff will be responsible for the informed consent.

Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation:

* Standard Wound Care: Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.

* CHG Wound Care: ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions (Appendix A) intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.

The remainder of the subjects' care will be similar for both arms and will follow current standard clinical practice at the University of Texas Medical Branch (UTMB).

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Patient unwilling or unable to provide consent.
No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery.
Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other.
Decision not to have skin closure (e.g. secondary wound closure, mesh closure).
Current skin infection.
Coagulopathy.
High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery).
Known allergy to CHG.
Incarcerated individuals.
Chorioamnionitis.
Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.

Arm && Interventions

Group	Intervention	Description
Standard Wound Care	Standard Wound Care	Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
CHG Wound Care	ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)	ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.

Primary Outcome Measures

Name	Time	Method
Satisfaction and QoL Questionnaire	Postpartum wound care visit (up to 10days postpartum)	We will be assessing through a survey patient satisfaction concerning dressing received and assess the quality of life while receiving either intervention (5 point Richter scale). A maximum score of 5: Strongly agree and a minimum score of 1: Strongly disagree. A higher score means a better outcome.

Secondary Outcome Measures

Name	Time	Method
Number of Participants That Resulted in Maternal Death	4 days postpartum	Death of participant during hospital stay (Yes or No)
Provider Satisfaction	Postpartum wound care visit (up to 10days postpartum)	Assessing health care providers opinion on the dressing care (5 point Richter scale). A maximum score of 5: Strongly agree and a minimum score of 1: Strongly disagree. A higher score means a better outcome.
Number of Participants With Composite Wound Complication	30 days postpartum	Defined as presence of any of the following within 30 days from surgery: Wound infection: Presence of either superficial or deep incisional SSI described as cellulitis/erythema and induration around the incision or purulent discharge from the incision site, with or without fever, such as necrotizing fasciitis (diagnosed based on necrotizing wound infection). Wound hematoma, seroma, or breakdown alone. (yes or No)
Number of Participants With Wound Breakdown	30 days postpartum	Opening of wound incision documented in the chart at the provider's discretion(Yes or No)
Number of Participants With Puerperal Fever	4 days postpartum	Temperature \> 100.4oF after first 24 hours or ≥101 oF any time. (Yes or No)